Assessing the effects of probiotics on sleep quality
Efficacy Assessment of Probiotics in Improving Sleep Indices
This study is testing if a probiotic called PS150 can help people with insomnia sleep better over 30 days.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 140 (estimated) |
| Ages | 20 Years to 60 Years |
| Sex | All |
| Sponsor | National Yang Ming Chiao Tung University Academic / other |
| Locations | 1 site (Taipei) |
| Trial ID | NCT06361368 on ClinicalTrials.gov |
What this trial studies
This study aims to evaluate the efficacy of PS150, a probiotic, in improving sleep indices among individuals suffering from insomnia. A total of 140 participants aged 20 to 60 with self-reported insomnia will be randomly assigned to receive either PS150 or a placebo for 30 days. The study will utilize various measures, including polysomnography, subjective sleep assessments, and biological sampling, to assess changes in sleep quality, anxiety, and microbiome functions. The trial is designed to be double-blinded to ensure unbiased results.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 20-60 who self-report insomnia symptoms and have a regular sleep cycle.
Not a fit: Patients with sleep disorders other than insomnia or those with significant medical conditions such as cancer or cardiovascular disease may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a novel, non-pharmacological treatment option for individuals struggling with insomnia.
How similar studies have performed: Previous studies have shown promising results for probiotics in improving sleep quality, suggesting potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. aged 20-60 years old, 2. self-reported Insomnia (PSQI ≥ 7 \& 22 \> ISI ≥ 12), 3. 17.5 \< BMI \< 35 kg/m\^2, and 4. regular sleep cycle. Exclusion Criteria: 1. used antibiotic, sleep aids, tranquilizers, or antipsychotic treatment within the last month, 2. used other probiotic products within the last month, 3. taking medications known to commonly induce sleep disorders (such as corticosteroids, antihistamines, and stimulants, etc.) or currently undergoing hormone therapy, including contraceptive pills, 4. have undergone hepatobiliary gastrointestinal tract surgery 5. lactic acid bacteria allergy, 6. with cancer, cardiovascular disease, psychiatric illness, or kidney disease, 7. with uncontrolled diabetes mellitus or hypertension, 8. with sleep disorders other than insomnia, 9. allergic to lactobacillus, 10. reported tobacco, alcohol, caffeine or drug addiction, 11. traveled to different time zone in long-distance trip within the last month, 12. participated in other interventional studies within the last three months, and 13. evaluated as unsuitable participant by PI.
Where this trial is running
Taipei
- Institute of Brain Science National Yang Ming Chiao Tung University — Taipei, Taiwan (Recruiting)
Study contacts
- Study coordinator: Yu En Kuo, Master
- Email: iankuo1106@gmail.com
- Phone: +886 975231262
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.